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Evaluation of the PPAR-y agonist pioglitazone in mild asthma: A double-blind randomized controlled trial

Anderson, J.R.; Mortimer, K.; Pang, Linhua; Smith, K.M.; Bailey, H.; Hodgson, D.B.; Shaw, Dominick E.; Knox, Alan J.; Harrison, Timothy W.

Evaluation of the PPAR-y agonist pioglitazone in mild asthma: A double-blind randomized controlled trial Thumbnail


Authors

J.R. Anderson

K. Mortimer

Linhua Pang

K.M. Smith

H. Bailey

D.B. Hodgson

Dominick E. Shaw

Alan J. Knox

Timothy W. Harrison



Abstract

Background

Peroxisome proliferator-activated receptor gamma (PPAR-γ) is a nuclear receptor that modulates inflammation in models of asthma. To determine whether pioglitazone improves measures of asthma control and airway inflammation, we performed a single-center randomized, double-blind, placebo-controlled, parallel-group trial.

Methods

Sixty-eight participants with mild asthma were randomized to 12 weeks pioglitazone (30 mg for 4 weeks, then 45 mg for 8 weeks) or placebo. The primary outcome was the adjusted mean forced expiratory volume in one second (FEV1) at 12 weeks. The secondary outcomes were mean peak expiratory flow (PEF), scores on the Juniper Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ), fractional exhaled nitric oxide (FeNO), bronchial hyperresponsiveness (PD20), induced sputum counts, and sputum supernatant interferon gamma-inducible protein-10 (IP-10), vascular endothelial growth factor (VEGF), monocyte chemotactic protein-1 (MCP-1), and eosinophil cationic protein (ECP) levels. Study recruitment was closed early after considering the European Medicines Agency’s reports of a potential increased risk of bladder cancer with pioglitazone treatment. Fifty-five cases were included in the full analysis (FA) and 52 in the per-protocol (PP) analysis.

Results

There was no difference in the adjusted FEV1 at 12 weeks (-0.014 L, 95% confidence interval [CI] -0.15 to 0.12, p = 0.84) or in any of the secondary outcomes in the FA. The PP analysis replicated the FA, with the exception of a lower evening PEF in the pioglitazone group (-21 L/min, 95% CI -39 to -4, p = 0.02).

Conclusions

We found no evidence that treatment with 12 weeks of pioglitazone improved asthma control or airway inflammation in mild asthma.

Citation

Anderson, J., Mortimer, K., Pang, L., Smith, K., Bailey, H., Hodgson, D., …Harrison, T. W. (2016). Evaluation of the PPAR-y agonist pioglitazone in mild asthma: A double-blind randomized controlled trial. PLoS ONE, 11(8), 1-15. https://doi.org/10.1371/journal.pone.0160257

Journal Article Type Article
Acceptance Date Jul 15, 2016
Online Publication Date Aug 25, 2016
Publication Date Aug 25, 2016
Deposit Date Nov 16, 2016
Publicly Available Date Nov 16, 2016
Journal PLoS ONE
Electronic ISSN 1932-6203
Publisher Public Library of Science
Peer Reviewed Peer Reviewed
Volume 11
Issue 8
Article Number e0160257
Pages 1-15
DOI https://doi.org/10.1371/journal.pone.0160257
Keywords Asthma, clinical trial, Pioglitazone
Public URL https://nottingham-repository.worktribe.com/output/804413
Publisher URL http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0160257
Contract Date Nov 16, 2016

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